Primary Light-Chain AmyloidosisPhase 2NCT07039578
Study Evaluating the Efficacy and Safety of CM336 Injection in the Treatment of Light-Chain Amyloidosis
A Phase 2 study testing CM336 Injection(Low dose group) and CM336 Injection(High dose group) in people with Primary Light-Chain Amyloidosis, run by Keymed Biosciences Co.Ltd at 2 sites in China.
Trial summary
to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults with Relapsed or Refractory Primary Light-Chain Amyloidosis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Light-Chain Amyloidosis
- What is being tested?
- CM336 Injection(Low dose group) and CM336 Injection(High dose group)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesChina
- Study dates
- 25 Jul 2025to 31 Jul 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary provision of written informed consent and ability to comply with protocol requirements.
- Age ≥18 years, any gender.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
- Confirmed diagnosis of primary light-chain (AL) amyloidosis.
- Relapsed or refractory primary AL amyloidosis.
- Measurable hematologic disease at screening (per protocol-defined criteria).
- Involvement of ≥1 amyloid-affected organ.
- Adequate organ function meeting all protocol-specified criteria within 3 days prior to first dose.
Who cannot join
- Current or prior diagnosis of multiple myeloma.
- Received anti-AL amyloidosis therapy within protocol-specified timeframe prior to first dose.
- Clinically significant cardiovascular or cerebrovascular disease.
- Any active or uncontrolled infection meeting protocol-defined criteria.
- Any other condition deemed by the Investigator to preclude safe study participation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Jian Li, 86+18610852525, lijian@pumch.cn
- Recruiting
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality
Gang An, 86+13502181109, angang@ihcams.ac.cn
About this study
Official title: An Open-Label, Multi-Center, Phase II Clinical Study Evaluating the Efficacy and Safety of CM336 Injection in the Treatment of Relapsed or Refractory Primary Light-Chain Amyloidosis
to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults with Relapsed or Refractory Primary Light-Chain Amyloidosis
- Conditions
- Primary Light-Chain Amyloidosis
- Being tested
- CM336 Injection(Low dose group), CM336 Injection(High dose group)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM336 Injection(Low dose group)Biological
subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol.
CM336 Injection(High dose group)Biological
subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Low dose group(CM336) | Experimental | Not described Receives: Biological: CM336 Injection(Low dose group) |
| High dose group(CM336) | Experimental | Not described Receives: Biological: CM336 Injection(High dose group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy after CM336 treatment
Hematologic complete response (hCR) rate
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start25 Jul 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Light-Chain AmyloidosisStudies of the same condition, open and under way.
- More trials run by Keymed Biosciences Co.LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jian Li, Principal investigator, Peking Union Medical College HospitalGang An, Principal investigator, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039578
- Sponsor's protocol ID
- CM336-026101
- Status last verified
- Nov 2025
- First submitted
- 18 Jun 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center, Phase II Clinical Study Evaluating the Efficacy and Safety of CM336 Injection in the Treatment of Relapsed or Refractory Primary Light-Chain Amyloidosis
- ClinicalTrials.gov ID
- NCT07039578
- Acronym / sponsor ID
- CM336-026101
- Conditions
- Primary Light-Chain Amyloidosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults with Relapsed or Refractory Primary Light-Chain Amyloidosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose group(CM336) | Experimental | Biological: CM336 Injection(Low dose group) |
| High dose group(CM336) | Experimental | Biological: CM336 Injection(High dose group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntary provision of written informed consent and ability to comply with protocol requirements.
- Age ≥18 years, any gender.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
- Confirmed diagnosis of primary light-chain (AL) amyloidosis.
- Relapsed or refractory primary AL amyloidosis.
Key exclusion criteria (5 listed)
- Current or prior diagnosis of multiple myeloma.
- Received anti-AL amyloidosis therapy within protocol-specified timeframe prior to first dose.
- Clinically significant cardiovascular or cerebrovascular disease.
- Any active or uncontrolled infection meeting protocol-defined criteria.
- Any other condition deemed by the Investigator to preclude safe study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CM336 Injection(Low dose group)subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol. | Biological | Low dose group(CM336) |
| CM336 Injection(High dose group)subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol. | Biological | High dose group(CM336) |
Primary outcome
To evaluate the efficacy after CM336 treatment
Time frame: up to 3 years
Hematologic complete response (hCR) rate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
Related trials for Primary Light-Chain Amyloidosis
Not yet recruitingPhase 3
Linvoseltamab Versus Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone (Dara-Vcd) in Adult Participants With Newly Diagnosed Systemic Light Chain Amyloidosis
Newly Diagnosed Amyloidosis, Amyloidosis Stage I-IIIA
RecruitingObservational study
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
Chronic Myeloproliferative Disorders, Leukemia
Active, not recruitingObservational study
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia
Not yet recruitingPhase 1/2
A Phase I/II Open-label, Single-arm, Multicenter Clinical Study to Evaluate the Safety and Efficacy of FKC289 in Subjects With Relapsed/Refractory Primary AL Amyloidosis
Primary Light Chain (AL) Amyloidosis
Active, not recruiting
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jian Li principal investigator
Peking Union Medical College Hospital
Gang An principal investigator
Institute of Hematology & Blood Diseases Hospital, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CM336 Injection(Low dose group) and CM336 Injection(High dose group) in people with Primary Light-Chain Amyloidosis, run by Keymed Biosciences Co.Ltd at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qian Jia (028-88610620, qianjia@keymedbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy after CM336 treatment (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.